Category Archives: MS Treatments and Drugs

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I’m just going to take it straight from Opexa’s press release that I found today on MarketWatch about the “upcoming Phase IIb clinical trial using Opexa’s T-cell therapy in patients with Secondary Progressive Multiple Sclerosis (SPMS).”

We’ve written about Opexa before because they seem to understand that NOT killing the patient is the best way to try and treat Multiple Sclerosis.

Opexa to Hold Preliminary Investigator’s Meeting for MS Trial at American Academy of Neurology Annual Meeting

Dr. Mark Freedman and other Members of Opexa’s SAB to introduce SPMS clinical trial to prospective trial physicians

THE WOODLANDS, Texas, Apr 19, 2012 (BUSINESS WIRE) — Opexa Therapeutics, Inc. OPXA -0.24% , a biotechnology company developing Tovaxin(R), a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company will be holding a preliminary meeting with prospective clinical trial investigators at the 64th Annual American Academy of Neurology (AAN) Meeting in New Orleans on April 24, 2012. The purpose of this meeting will be to discuss the upcoming Phase IIb clinical trial using Opexa’s T-cell therapy in patients with Secondary Progressive Multiple Sclerosis (SPMS).

“We are honored to introduce our next clinical trial to a group of invited neurologists at this year’s AAN meeting in New Orleans,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “The meeting will be an opportunity to discuss with select clinicians and their study coordinators potential participation in the SPMS clinical trial as well as present the final protocol for the trial including the design, structure and patient selection criteria. This is an exciting time for Opexa, neurologists and SPMS patients as this study will provide an innovative opportunity for treatment in an area where currently there are very few treatment options. The annual AAN meeting is an excellent forum for the MS community to discuss and present new therapies that could have an important impact on the treatment of MS. We are pleased that Tovaxin is generating a great deal of enthusiasm among physicians, key opinion leaders and patients in the lead up to this meeting and are equally pleased to be advancing our clinical plans for Tovaxin.”

Mark Freedman, M.D., director of the Multiple Sclerosis Research Unit at the Ottawa Hospital and member of Opexa’s Scientific Advisory Board, commented, “I am pleased to contribute my expertise to Opexa with their design and planning of this Phase IIb study. Opexa is now in the process of selecting clinical trial investigators and finalizing the remaining steps in order to conduct a study of optimal quality. I am pleased to facilitate the introduction of the Phase IIb study to prospective clinical trial investigators at this year’s AAN meeting. Patients with SPMS have few treatment options and Tovaxin’s safety profile certainly justifies investigation of this therapy in the challenging SPMS patient population.”

The proposed Phase IIb clinical trial will be a randomized, double-blind, placebo-controlled study of Opexa’s T-cell therapy in SPMS patients with evidence of disease progression without associated relapses. The study, to be initiated once the necessary resources are secured, is expected to treat approximately 180 patients in up to 30 sites in the United States and Canada with annual courses of treatment for two years.

About Opexa

Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS). The Company’s leading T-cell therapy, a personalized cellular immunotherapy treatment, is in clinical development targeting both Secondary Progressive and Relapsing Remitting MS. Opexa’s T-cell therapy is derived from T-cells isolated from peripheral blood, expanded ex vivo and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time.

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “expects,” “believes,” “anticipates,” “estimates,” “may,” “could,” “intends,” and similar expressions are intended to identify forward-looking statements. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding the development of the Company’s product candidate, Tovaxin, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our capital position, the ability of the Company to enter into and benefit from a partnering arrangement for the Company’s product candidate, Tovaxin, on reasonably satisfactory terms (if at all), our dependence (if partnered) on the resources and abilities of any partner for the further development of Tovaxin, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of developing a marketable product, our ability to raise additional capital to continue our treatment development programs and to undertake and complete any further clinical studies for Tovaxin, the success of our clinical trials, the efficacy of Tovaxin for any particular indication, such as Relapsing Remitting MS or Secondary Progressive MS, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights (including for Tovaxin), the risk of litigation regarding our intellectual property rights, the success of third party development and commercialization efforts with respect to products covered by intellectual property rights that the Company may license or transfer, our limited manufacturing capabilities, our dependence on third-party manufacturers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date made. We assume no obligation or undertaking to update any forward-looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in our reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2011.

If I was paying money to monitor those who I may perceive as a threat (my husband does have Multiple Sclerosis and I am a health care activist and I guess that does make us scary threatening to some) I would hope that those I pay have some, what’s the word–subtlety.

For those of you not familiar with Cyveillance, they monitor websites; more details below from Wikipedia. They were a big visitor to Illness and Insurance Hell all during 2009 when President Obama was trying to pass health care reform.

Cyveillance, founded in 1997, is a private Internet-monitoring company based in Arlington, Virginia and provides an intelligence-led approach to security. The company’s subscription-based product, the Cyveillance Intelligence Center, is a hosted solution. Companies hire Cyveillance to monitor for Internet risks such as: Information leaks; Phishing and malware attacks and other online fraud schemes; Sale of stolen credit and debit card numbers; Threats to executives and events; Counterfeiting; and Trademark and brand abuse.
Cyveillance was bought in May 2009 by the UK firm QinetiQ, for an initial cash consideration of $40 million.[1] Cyveillance’s clients include the pharmaceutical industry and entities within the entertainment industry, particularly music and movie concerns, specifically, the RIAA and MPAA. Cyveillance runs scans which attempt to gain unauthorized access to P2P networks, Web servers, IRC servers, FTP servers, and mail servers, searching for mp3 audio files and movie titles. After running the scan, the site scanned is archived, and the information sold to the RIAA and/or MPAA.[citation needed]

Sanofi also listed the side-effects as headache, rash, fever, nausea, flushing, hives, and chills, leaving out the deaths reported in the clinical trials.

I also was very wary when I read the study and they were touting the drug as being able to prevent disability outright. It was even reported that it may reverse brain damage from MS. Nothing short of a miracle, right? Or a selling point worthy of $20.1 billion?

If you have been following this blog because you or a family member has Multiple Sclerosis you may know about the Sanofi takeover of Genzyme. Alternately, if you are one the many pharmaceuticals or investors or PR and advertising firms that visit us, you already do know that Sanofi completed the $20.1 billion buyout of Genzyme.

Which brings us to Campath (acquired from Bayer by Genzyme) now known, or trying to be known, as Lemtrada. We have written about it here because of the shameful desire to increase the price of a relatively inexpensive cancer treatment to $60,000 per year for Multiple Sclerosis treatment.

It is NOT YET APPROVED for use by the FDA. Campath/Lemtrada is still in clinical trials. Here is a link to the latest in their Clinical Trials.

At one point, Genzyme was giving Campath away for compassionate use in cancer patients. This was done by Genzyme to erase the yearly sales figures so that when the same drug rolls out (when approved) the $60,000 per year price sticker for Multiple Sclerosis won’t have a sales comparison number–of something much, much cheaper. Redefines the whole meaning of compassion, doesn’t it?

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Health Care Reform:

While the Affordable Care Act is not yet a law–we still have until 2014 for the whole thing to go into effect–the GOP is back to using their favorite catch phrase, “death panels.”

Here is a link to an article in Talking Points Memo about Rep. Phil Gingrey (R-GA) raising the dirty spectre of death panels and rationing yet again. Just an FYI, Rep. Gingrey voted to abolish Medicare. I think the good doctor should know better than to espouse what he does, but here’s the quote:

We’re the only democratic and industrialized nation in the world without a universal plan; a plan where anyone can buy into a risk pool and get themselves covered no matter what. We all get sick, it’s part of the human condition. It’s how we treat ourselves that defines our society.

If government is so bad, why does Dr. Gingrey want to use government to sharply cut medical malpractice awards? Won’t the free market just sort things out on its own?

But if Dr. Gingrey is speaking about the government creation of a high risk pool to help my husband and all Americans with pre-existing conditions get access to health care by purchasing insurance that will cover them, then I suggest he re-read his Hippocratic Oath.

Are we being threatened by rising costs? Yes. Why? Because Dr. Gingrey and his GOP ilk refuse to expand Medicare to Everyone. A national health plan that would compete for customers may inspire the private health insurers to actually produce a good product. Competition does that. As it is now, the private health insurers have zero competition.

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Now onto the National Multiple Sclerosis Society:

We got a flyer from the National MS Society the other day about their teleconference series that, “is designed to support individuals with MS through the continuum of their work experiences; from staying employed, to retraining and on to post-employment options. Understanding how to access vital resources will help individuals make the best choices through any stage of their workforce journey.”

With all the money the National MS Society takes in (and spends), this piece of writing just sent me over the edge as it purports to say something without saying anything at all. They paid for that with your donation dollars. And it gets worse:

Applying Through Your Employer’s Long Term Disability Benefits When MS Progresses

Featured speaker Lisa Kantor, LLP from Kantor and Kantor will share her expertise as an advocate who has successfully represented people in Employment Retirement Income Security Act (ERISA) benefit claims for over 18 years. If you have MS and Long Term Disability Insurance through your employer, you will want to know how to apply for and access these vital benefits.

Let me just begin by saying that the whole reason I’m here writing this, the whole reason this Foundation exists is because of the way my husband was treated both by his Long Term Disability insurance carrier, CIGNA.

He was denied his benefits by CIGNA. Twice. We had no where to turn for help, including the MS Society at the time.

This sort of teleconference series makes the National MS Society look good, but doesn’t really help. And with all the money they have, imagine what they could do. They could start by lobbying Congress to fix ERISA–that would go a long way in helping not just those with MS but all who have been denied their benefits or who have been mistreated by their health insurer.

Listening to Ms. Kantor may be helpful, she may even gain a few clients from this teleconference, but she can’t help you “apply for and access these vital benefits.” She simply cannot and that has nothing to do with Ms. Kantor.

See, one cannot actually access their long term disability benefits. I wrote extensively about that over at Illness and Insurance Hell.

Your insurance carrier starts the process while you are still on short-term disability; they will insist you apply for Social Security benefits and prove that you have been through that process or else they’ll deny your claim. They will even offer you help with one of their attorneys to make sure you go through the Social Security process.

To make matters even worse, they will obfuscate the truth (that’s called lying) in the face of medical evidence; they make things up. And when they are threatened with legal action, they send photographers (bad ones I’d like to add) to your house to photograph you and your family. My husband has lesions on his brain and spinal cord, could the guy with the camera, snapping away at us, somehow disprove that?

Which brings me back to the Affordable Care Act, the Ryan plan to abolish Medicare and the GOP still trying to get rid of health care reform.

I ask this: If the GOP succeeds in repealing health care (doubtful) but say they do, then the provisions in the law that help people, that stop lifetime caps, give seniors free preventative care, that fill the Medicare donut hole, that stops insurers from retroactively cancelling your plan, that gives Medicare drug discounts–if the GOP stops all this then what good is that $8,000 Ryan Voucher?

A new article in the Annals of Neurology has made its way across various blogs and discussions about Multiple Sclerosis around the internet. It’s about CCSVI. And when we saw this article’s head line here, “Cerebrospinal Drainage Not Tied to Multiple Sclerosis,” along with the disclaimer:

Several of the researchers on this study disclosed financial relationships with pharmaceutical companies, including Pfizer, Sanofi-Aventis, and Merck-Serono.

Our first reaction was that any study that is to be done (especially one involving a treatment that could potentially make MS drugs a thing of the past) the authors need to be free of any ties to pharmaceutical companies. The authors are:

All of the above pharmaceuticals make Multiple Sclerosis drugs and have a large stake in those drugs. They cost a lot of money. See more about how much money here, here and here. And here as well.

This Foundation is not going to go into the details of the findings of the study. That is best left to experts in this field.

And as we find discussions on this study, we will post them here like the one at the MS blog on About.com. I threw in my two cents as well.

This Foundation just wants to point out the conflicts of interest to demonstrate that studies like these need to be done by those free and clear of the ties as shown above, like being members of the board of Pfizer, Sanofi and Merck. Seriously.

The Reformed MS Society started much in the same way this Foundation started with one spouse fighting for the rights and treatments for another.

Mr. Steven Simonyi-Gindele began the Society after his wife, Ruth, who suffers from Multiple Sclerosis, had the treatment for CCSVI. It is theorized that MS may indeed be a vascular disease and that the resulting destruction of myelin comes from iron deposits in the brain (due to lack of blood flow) which triggers the autoimmune response.

CCSVI, or chronic cerebrospinal venous insufficiency, is treated with balloon angioplasty and stenting of the blocked veins.

The Reformed Multiple Sclerosis Society is your best source for information regarding the treatment for CCSVI. They are not beholden to donations from pharmaceutical companies. We will also start to keep our own section on CCSVI and update with information as it becomes available. I spoke with Elizabeth of the Reformed MS Society back in November of last year. They are a wonderful and accessible organization and if you have any questions, they will try and answer them. Their office number is 604-639-4405.

In short, the procedure was a “successful failure,” in that we successfully determined that I do have significant abnormalities in the vascular system associated with my central nervous system (a very important discovery), but those abnormalities unfortunately could not be remedied during the procedure.

And with the pharmaceutical companies regurgitating cancer drug after cancer drug as the “newest therapy” in their MS arsenal–reformulated and slapped with a higher price tag–it’s time for some real research into the disease and not research into how more money can be made from the disease, year-after-year with no end in sight.

Before I get into trouble with the people of the Basque region, please know that pinpointing your location within Spain is just recognizable for those unfamiliar with the country, region or your really good food.

Finding the genetic markers would give researchers the ability to find a cure for MS and also, possibly, a host of other autoimmune diseases. Finding a cure does not sit too well with companies who make millions (or as Mr. Termeer of Genzyme has postulated, billions) from just maintaining the disease.

Based on the tools developed by the Bioinformatics engineers at the University of the Country of Basque, BioDonostia is using the tools for medical research. It’s a cooperative research system where the objective isn’t a higher stock price, but actually working out a solution to our most basic human problems.

I just wanted to highlight the fact that this research is taking place–but not in this country where we have a lot of money being thrown at Multiple Sclerosis: a lot of fundraisers, a lot of 501(c)(3)’s raising millions to fund research but also to fund salaries, rent on high priced real estate, brochures touting their work, and the other expenses with running a high profile foundation.

Could it be that money isn’t given to fund research to find a cure when so money is to be made from not finding a cure?

My understanding of finding the genetic marker for any disease would be, as Mr. Inza puts it above, worthy of a Nobel Prize. The rest of the article is here, and I urge you to read it. It is incredibly interesting, especially for you nerdy people out there like me, how these researchers are converting the genes into numbers and then using a DNA chip (which fits in your hand) to store the information. Your genome on a chip!

Now research that used to take decades on a single gene can be sorted out much more quickly. With the use of the chip, a researcher can begin to look at the genetic make-up of someone with Multiple Sclerosis and compare that DNA with someone without the disease and see where the genetic differences may lie. We hope they succeed quickly.

“When the DNA from a sample of a person’s body is inserted behind the chip, each gene goes to its allotted slot, as it were”, stated Mr Inza. Then images of colours, partitioned into these slots, are obtained. These colours represent “levels of intensity and are proportional to the level of expression of each one of these genes. These are translated into numbers”. José Antonio Lozano adds, “The numbers express a level of fluorescence, the intensity of the signal.” With these numbers, computer models enter the scene.